UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002827 |
|---|---|
| Receipt number | R000003441 |
| Scientific Title | Analysis of innate immunity responses in infectious diseases. |
| Date of disclosure of the study information | 2009/12/07 |
| Last modified on | 2014/08/31 21:03:19 |
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Basic information
Public title
Analysis of innate immunity responses in infectious diseases.
Acronym
Innate immunity responses in infectious diseases.
Scientific Title
Analysis of innate immunity responses in infectious diseases.
Scientific Title:Acronym
Innate immunity responses in infectious diseases.
Region
| Japan |
Condition
Condition
To examine the modulation of Toll-like receptor 2 and CD64 on monocytes in various infectious diseases
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
| Infectious disease | Laboratory medicine | Operative medicine |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of useful biomarkers to excess the severity in infectious diseases
Basic objectives2
Others
Basic objectives -Others
Biomarker to discriminate infectious diseases from non-infectious inflammatory diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To excess useful baiomarkers to rapidly predict exacerbation/remission and reccurence/complete cure in infectious diseases
Key secondary outcomes
Biomarker to discriminate infectious diseases from non-infectious inflammatory diseases
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Our study population is patients with various inflammatory disease, from who were Informed consent was obtained in accordance with a protocol approved by the Nagasaki University Ethics Committee, and blood sample from healthy volunteers is taken as control.
Key exclusion criteria
Patients in whom 10 mL blood sampling may be have harmful effects. Severe anemia etc.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sigeru Kohno |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Molecular Microbiology and Immunology
Zip code
Address
1-7-1, Sakamoto, Nagasaki, 852-8501, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kakeya |
Organization
Graduate School of of Biomedical Sciences, Nagasaki University
Division name
Department of Molecular Microbiology and Immunology
Zip code
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
095-819-7273
Homepage URL
kakeya-ngs@umin.ac.jp
Sponsor or person
Institute
Department of ,
Graduate School of Medicine, Nagasaki University, Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Cardiovascular, Respiratory and Metabolic Medicine,
Graduate School of Medicine, Kagoshima University, Japan
Name of secondary funder(s)
Department of Advanced Medicine and Development, BML, INC. Saitama, Japan
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
長崎大学病院（長崎県）Graduate School of Medicine, Nagasaki University、鹿児島大学病院 （鹿児島県）Graduate School of Medicine, Kagoshima University
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
TLR2 and CD64 expression level on monocyte may provide an important clinical information in a dissimilar fashion to the conventional inflammatory markers.
Management information
Registered date
| 2009 | Year | 12 | Month | 02 | Day |
Last modified on
| 2014 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003441
